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Futibatinib, an irreversible FGFR1-4 inhibitor, in patients with advanced solid tumors harboring FGF/FGFR aberrations: a phase I dose-expansion study.

Funda Meric-BernstamRastislav BahledaCinta HierroMarc SansonJohn A BridgewaterHendrik-Tobias ArkenauBen TranRobin Kate KelleyJoon Oh ParkMilind JavleYaohua HeKarim A BenhadjiLipika Goyal
Published in: Cancer discovery (2021)
Futibatinib, a highly selective, irreversible FGFR1-4 inhibitor, was evaluated in a large multihistology phase I dose-expansion trial that enrolled 197 patients with advanced solid tumors. Futibatinib demonstrated an objective response rate (ORR) of 13.7%, with responses in a broad spectrum of tumors (cholangiocarcinoma and gastric, urothelial, central nervous system, head and neck, and breast cancer) bearing both known and previously uncharacterized FGFR1-3 aberrations. The greatest activity was observed in FGFR2 fusion/rearrangement-positive intrahepatic cholangiocarcinoma (ORR, 25.4%). Some patients with acquired resistance to a prior FGFR inhibitor also experienced responses with futibatinib. Futibatinib demonstrated a manageable safety profile. The most common treatment-emergent adverse events were hyperphosphatemia (81.2%), diarrhea (33.5%), and nausea (30.4%). These results formed the basis for ongoing futibatinib phase II/III trials and demonstrate the potential of genomically selected early-phase trials to help identify molecular subsets likely to benefit from targeted therapy.
Keyphrases
  • phase ii
  • clinical trial
  • open label
  • phase iii
  • copy number
  • randomized controlled trial
  • gene expression
  • double blind
  • dna methylation
  • single molecule
  • smoking cessation
  • combination therapy